SeaStar Medical's Cytopheretic Device has received Breakthrough Device Designation from FDA
SeaStar Medical, a medical device company focused on developing innovative solutions to mitigate the impact of hyperinflammation on vital organs, has recently announced that it has obtained the Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its patented Selective Cytopheretic Device (SCD). This first-in-class SCD is intended for use with patients in the intensive care unit (ICU) who are experiencing acute kidney injury (AKI) and acute on chronic liver failure. This designation marks the third time that the FDA has granted SeaStar Medical this recognition for the SCD, and it is anticipated to expedite the clinical development and regulatory review process for using the device in this specific patient group.
Hepatorenal syndrome is a medical condition characterized by a sudden deterioration in kidney function, often instigated by a hyperinflammatory process in individuals with advanced liver cirrhosis. The condition is closely linked to a significantly high mortality rate, with most affected patients facing a dire prognosis, often succumbing to renal failure within a matter of weeks.
Hyperinflammation refers to an excessive production or activity of inflammatory cells, which can result in damage to vital organs. This state occurs when the body produces an excess of inflammatory effector cells and other molecules, which can have toxic effects on crucial organs and may lead to multi-organ failure and, in severe cases, death. This phenomenon is frequently referred to as a "cytokine storm."
What sets the Selective Cytopheretic Device (SCD) apart is its unique approach. It selectively targets the most highly activated proinflammatory neutrophils and monocytes, distinguishing it from other blood-purification methods. SeaStar Medical's observations have shown that these highly activated immune cells can be effectively deactivated in a low-calcium environment. The SCD therapy mimics this natural process by creating a specialized micro-environment that attracts these highly activated effector cells and neutralizes them. Subsequently, these deactivated cells are reintroduced into the bloodstream, signaling the body to prioritize repair and recovery.